A Phase 1 interventional study of REGN2009 and placebo in Healthy Volunteers, sponsored by Regeneron Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-10.
Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment
This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.
Regeneron Pharmaceuticals is the lead sponsor of 410 studies on the registry; 93 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
Drug: REGN2009 · Other: placebo
Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
Drug: REGN2009 · Other: placebo
Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
Drug: REGN2009 · Other: placebo
Number of TEAEs
The primary endpoint in this study is the incidence and severity of Treatment Emergent Adverse Events (TEAEs) in healthy volunteers treated with REGN2009 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 15.
Time frame: day 1 to day 106/ visit 15
The record gives a start of Jun 2013, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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